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FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

Posted 07 August 2017 | By Michael Mezher 

FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks.

According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also improved participants' recognition of the drugs' benefits and improved their overall processing of the ad.

Currently, DTC drug ads are required to list a product's major risks alongside its benefits to ensure a "fair balance" of information. But, there is an ongoing debate over the best way to present risk information and previous research has yielded mixed results in terms of consumers' ability to recall information when presented with different levels of risk information.

"Limiting the risks to those that are serious and actionable serves a dual purpose. First, it may reduce the cognitive burden that may result from having to process a large amount of information. Second, serious and actionable risks may be perceived as more relevant, thus improving attention and comprehension of the risk statement," the authors write.

To test that hypothesis, and to determine the effects of the disclaimer that not all risks were presented, the authors surveyed three groups of 500 consumers that self-reported as having depression, insomnia or high cholesterol.

Each participant was shown one of four versions of an ad for a drug relevant to their condition—Abilify (aripiprazole) for depression; Lunesta (eszopiclone) for insomnia; and Crestor (rosuvastatin calcium) for high cholesterol—with each version presenting either the drug's unedited risk statement or a more limited one, with or without a disclosure that not all risks were presented.

The number of risks presented for each drug shifted from 17 to 8 for the depression group, from 11 to 6 for the insomnia group and from 6 to 4 in the high cholesterol group based on whether the ad presented the unedited or limited set of risks.

After viewing the ads, the participants were then given a questionnaire in order to measure how they reacted to the disclosure statement and how they retained and perceived benefit and risk information in the ad.

Based on responses to the questionnaire, the authors found that participants were better able to recall the serious and actionable risks when shown the limited risk statement in all three illness groups. But, when it came to recognizing those risks, the authors only found a statistically significant effect supporting limited risk statements in the depression and insomnia groups.

The authors also found that participants shown the limited risk statements could accurately recognize more benefits than participants shown the full risk statement in the depression and insomnia groups, though they did not see an effect one way or the other in the high cholesterol group.

While the authors say that more research is needed to evaluate their findings, they conclude that an alternative, limited approach to presenting risk information could be viable for DTC advertising.



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